BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3870906 · Received June 12, 2014

    Report

    Report Number
    3004209178-2014-85715
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER CALLED IN TO REPORT BEING TREATED FOR LOW BLOOD GLUCOSE LEVELS BY PARAMEDICS. CUSTOMER STATES HAVING BLOOD GLUCOSE LEVEL OF 40 MG/DL AT TIME OF EVENT AND THAT HE HAD TRIED TO USE HIS SENSORS BEFORE BUT THEY WERE EXPIRED. PATIENT HAD MISSED A MEAL EARLIER IN THE DAY AND REFUSED TO BE TAKEN TO THE HOSPITAL. CUSTOMER DECLINED TROUBLESHOOTING AND REQUESTED ORDERING NEW SENSORS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347409 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention